510(k) · Cleared
ClearedValeo C Spacer System, Valeo II C IBF Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amedica Corp. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Dec 8, 2014 as substantially equivalent to K130177 (Medtronic Sofamor Danek USA, Inc., 2013) after a 115-day review. Its family tree reaches back 1 generation to 2013. 532 later devices descend from it.
- Decided
- Dec 8, 2014
- Review
- 115 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K130177 (2013). 532 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK130177 Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2013
- This deviceK142264 Valeo C Spacer System, Valeo II C IBF DeviceAmedica Corp. · 2014
- Descendant · cites it directly · 441 of its ownK150362 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2015
- Descendant · 2 generations on · 315 of its ownK160125 Cascadia Interbody SystemK2m · 2016
- Descendant · 2 generations on · 289 of its ownK163491 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2017
- Descendant · cites it directly · 226 of its ownK151322 Amendia Interbody Fusion DevicesAmendia, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 169 of its ownK162264 Cascadia Interbody SystemK2m, Inc. · 2016
Showing 5 of 532 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 532 · See all- K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2015 · cites it directly441descendants
- K160125Cascadia Interbody SystemK2m · 2016 · 2 generations on315descendants
- K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2017 · 2 generations on289descendants
- K151322Amendia Interbody Fusion DevicesAmendia, Inc. · 2015 · cites it directly226descendants
- K162264Cascadia Interbody SystemK2m, Inc. · 2016 · 3 generations on169descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K130177 | Anatomic Peek Cervical Fusion System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| 0 (this device) | K142264 | Valeo C Spacer System, Valeo II C IBF Device | Amedica Corp. | 2014 | — |
| +1 | K150362 | NuVasive CoRoent Small Interbody System | Nu Vasive, Incorporated | 2015 | — |
| +2 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| +2 | K163491 | NuVasive CoRoent Small Interbody System | Nu Vasive, Incorporated | 2017 | — |
| +1 | K151322 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2015 | 1 |
| +3 | K162264 | Cascadia Interbody System | K2m, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 31 | 0 |
| 2018 | 27 | 0 |
| 2019 | 38 | 0 |
| 2020 | 60 | 0 |
| 2021 | 46 | 0 |
| 2022 | 57 | 0 |
| 2023 | 74 | 0 |
| 2024 | 62 | 0 |
| 2025 | 67 | 0 |
| 2026 | 58 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ODP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K130177 | Anatomic Peek Cervical Fusion SystemSummary page 6…ifications to the Valeo™ Spacer System and Valeo™ II Interbody Fusion Device System are substantially equivalent to the predicate ANATOMIC PEEKTM Cervical FUSION SYSTEM (K130177) with respect to indications, design, and performance. Substantial Equivalence: The Valeo™ Spacer System and Valeo™ II Interbody… | 2013 |
What descends from it? (532)
See all 5328 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150362 | NuVasive CoRoent Small Interbody System | 2015 | 441 |
| K151322 | Amendia Interbody Fusion Devices | 2015 | 226 |
| K150619 | CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System | 2015 | 107 |
| K150765 | LDR Spine ROI-C Cervical Cage System | 2015 | 59 |
| K160528 | ANATOMIC PEEK PTC Cervical Fusion System | 2016 | 23 |
| K143518 | Valeo Spacer System and Valeo II Interbody Fusion Device System | 2015 | 5 |
| K242303 | MOD-C | 2026 | 0 |
| K173453 | Valeo® C+CSC with Lumen Interbody Fusion Device | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System –Cervical are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System…
Read the full statement (263 words)
Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System –Cervical are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System –Cervical are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc space to the C7-T1 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System –Cervical are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Valeo™ Spacer System-L and Valeo™ II Interbody Fusion Device System - Lumbar are indicated for use with autograft bone graft in patients with DDD at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Valeo™ Spacer System-L and Valeo™ II Interbody Fusion Device System - Lumbar are intended to be used with supplemental spinal fixation systems, such as Preference Pedicle Screw System. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142264 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142264: Valeo C Spacer System, Valeo II C IBF Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142264
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026